EZ2 Connect MDx-IVD Designed to perform automated isolation and… — Class II medical device recall Z-1508-2024
Ongoing recall by Qiagen Sciences LLC, reported 2024-04-17, distributed nationwide. Insufficient welding leads to the heater cable becoming brittle and present with an error: ERROR 3481 HEATER U
| Recall number | Z-1508-2024 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Qiagen Sciences LLC, Germantown, MD, United States |
| Recall initiated | 2024-03-04 |
| Classified | 2024-04-10 |
| Reported by FDA | 2024-04-17 |
| Distributed | Nationwide (US) |
| UPC / GTIN / UDI-DI | 04053228040576 |
| Model numbers | 9003230 |
Product
EZ2 Connect MDx-IVD Designed to perform automated isolation and purification of nucleic acids in molecular diagnostic and/or molecular biology applications. Model Number: 9003230
Reason for recall
Insufficient welding leads to the heater cable becoming brittle and present with an error: ERROR 3481 HEATER UNABLE TO REACH TEMPERATURE; the instrument may stop, and the sample being processed will be lost
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-1508-2024. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.